Device recall

Z-0227-06: Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with…

FDA device recall · Class III · Smiths Medical PM, Inc.

Key facts

Recall number (Z-number) Z-0227-06
Recall event 33375
Product Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG, Standard SPO2 option and battery.
Product code DPS
Recalling firm Smiths Medical PM, Inc.
Recall class Class III
Status Terminated
Termination date Jun 27, 2007
510(k) numbers K010770, K011177
FEI number 2183502

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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